A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

Trial Profile

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

Completed
Phase of Trial: Phase II

Latest Information Update: 20 May 2015

At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ASPIRE
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 20 May 2015 Results of pooled data from ADVANCE, QUEST 1 and 2 trials comparing efficacy of simeprevir and telaprevir presented at the 20th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
    • 20 Nov 2013 Simeprevir approved by Health Canada.
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